Study Start Up Lead (CONTRACT)

Initial Therapeutics, Inc.; Boston (MA); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading biopharmaceutical company seeks a Clinical Trial Operations manager to spearhead start-up activities for new clinical studies. The ideal candidate will bring 8+ years in clinical trials management, ensuring compliance and driving operational initiatives to achieve project milestones effectively. A strong emphasis on teamwork and communication is crucial in this dynamic role.

Benefits

Competitive health, dental, and vision coverage

Discretionary time off

Paternity leave

401(k) package

Generous transportation stipend

Qualifications

• 8+ years experience supporting and independently managing clinical trial activities.
• Strong knowledge of ICH/GCP regulations.
• Ability to travel approximately 20%.

Responsibilities

• Lead and support study start-up activities, including regulatory submissions.
• Drive start-up activities, ensuring compliance with local, ICH, and GCP regulations.
• Collaborate with internal teams and external vendors on study start-up.

Skills

Communication

Team Collaboration

Problem Solving

Education

BA/BS degree

Job description

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

The Perfect Addition to Our Team

You are excited about the opportunity to spearhead clinical trial start up activities. You are well organized and like to share best practices in clinical operations and study start up. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company.

The Opportunity

This individual will lead varying operational initiatives across on-going and new clinical studies for study start up and enrollment. This role will support the overall planning and management of clinical trials, including CRO and vendor oversight, to achieve project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures.

Responsibilities

• Lead and/or support Sr. CTMs/CTMs with study start up and maintenance activities, including regulatory submissions, country and site selection, site budget management, site activation, ICF review, etc. Collaborate with Sr. CTM/CTMs on developing study specific strategic start up or protocol amendment implementation plans.
• Accountable for driving start-up activities including timely site selection and activation, EC submissions and query responses, document collection, and protocol amendment activities.
• Reviewing country-level ICFs and related site or patient facing materials and routing for approval by required functional areas.
• Review and approve site activation packages and regulatory documentation, ensuring complete and accurate information tracked in the appropriate databases.
• Proactively identify and support resolution/escalation of issues impacting start up or trial execution.
• Collaborate and communicate with the cross-functional trial team, including collaborating with internal team members and external vendors on related study start up activities.
• Ensure that all assigned start up activities are on track and support study deliverables.
• Partner with relevant stakeholders to develop and implement appropriate study-specific training and kick-off meetings to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3^rd parties).
• Support site training and monitoring activities and visit clinical study sites as needed.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives ourbehavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapiesfor patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• BA/BS degree with 8 + years of combined experience supporting and independently managing clinical trial activities.
• Strong knowledge of ICH/GCP and regulatory requirements, with a strong preference for experience with EU-CTR.
• Strong experience in the drug development process, including trial design, trial planning and management, and CRO and vendor oversight.
• Excellent verbal and written communication skills.
• Proven ability to work effectively across functions.
• Ability to travel approximately 20% of the time, as determined by the needs of the business.
• This is a US based remote position, with preference given to local New England based candidates. This role will require a minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-JF1 #LI-Remote

The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

Privacy Statement

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